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Resolution II Clip

by Boston Scientific

510(k) K102764

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK102764 Date22 Dec 2010ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-3056-2011 FDA Unclassified (pre-2012) initiated 19 Jul 2011 on shared 510(k) K102764

    Boston Scientific has received reports where, following clip deployment, the alignment of the clip and delivery system does not allow for the withdrawal of the delivery system away from the clip, resulting in tissue trauma, increased bleeding and the clip being pulled off tissue as the delivery system is withdrawn.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
PKL
FDA applicant
Boston Scientific Corporation
Device class
Class II
Regulation
21 CFR Part 876.4400
Advisory committee
Gastroenterology, Urology
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 6 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Resolution II Clip is a hemostatic metal clip for the GI tract, designed for endoscopic hemostasis, marking, closure, and anchoring of jejunal feeding tubes. It is radiopaque and intended for use in gastroenterology and urology procedures.

The device is supplied as a pre-loaded, single-use clip on a flexible delivery system, available in 155 cm and 235 cm sizes, packaged in boxes of 1, 10, or 20 clips. It is designed to be ready-to-use for emergency bleeding situations and allows for opening and closing up to five times prior to deployment to aid in repositioning.

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Questions

AI-generated answers, 6 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Resolution II Clip used for?

    The Resolution II Clip is designed for endoscopic hemostasis, marking, closure, and anchoring of jejunal feeding tubes in the GI tract, and is intended for use in gastroenterology and urology procedures to control bleeding and secure tissue or devices.

  • How is the Resolution II Clip supplied and is it reusable?

    The Resolution II Clip is supplied as a pre-loaded, single-use clip on a flexible delivery system, packaged in boxes of 1, 10, or 20 clips, and is intended for one-time use only; it is not designed for reuse, reprocessing, or resterilization after deployment.

  • What sizes and features does the Resolution II Clip delivery system have?

    The Resolution II Clip is available with delivery system lengths of 155 cm and 235 cm, is radiopaque for visibility under imaging, and allows the clip to be opened and closed up to five times before deployment to assist with positioning during endoscopic procedures.